Sch 1B Pt 10 para 3
The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; (b) the technical design specifications, including standards, that will be applied and, where the relevant designated standards, and/or normative documents will not be applied in full, the means that will be used to ensure that the essential requirements of these Regulations that apply to the regulated measuring instruments will be met applying other relevant technical specifications; (c) the design control and design verification techniques, processes and systematic actions that will be used when designing the regulated measuring instruments pertaining to the instrument category covered; (d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (e) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out; (f) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (g) the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.